The Journal of urology · 2026
Implantable Tibial Neuromodulation Therapy Improves Symptoms of Urge Urinary Incontinence From the TITAN 2 Pivotal Study.
СтатьяМногоцентровое исследованиеКлиническое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Lee Una, Xavier Keith, Carey Jeffrey, Pickering Alison, Harris-Hicks Janet, Giusto Laura, Finkelstein Kenneth, Kim Jason, Yaklic Jerome, Gillespie Emily, Grunow Nathan, Benson Kevin
Аннотация
PURPOSE: The Medtronic implantable tibial neuromodulation system is a leadless, rechargeable, minimally invasive option intended to treat the symptoms of urge urinary incontinence (UUI), a common condition that significantly impairs quality of life. TITAN 2 is a pivotal study evaluating safety and effectiveness of the Medtronic implantable tibial neuromodulation system. The results through 12 months are reported.
MATERIALS AND METHODS: This prospective, multicenter, single-arm investigational device exemption study enrolled eligible overactive bladder subjects with UUI. The primary end point was the percentage of subjects who had ≥ 50% reduction in UUI episodes/day after 6 months. Safety was characterized as the rate of adverse device effects (ADEs). Data are reported as mean ± SD or with 95% CIs.
RESULTS: Of 126 implanted subjects, 95% were female, the mean age was 63 ± 14 years, and BMI was 35 ± 9 kg/m2. The primary objective was met with 59% of subjects achieving ≥ 50% improvement in UUI episodes/day (95% CI: 49%-67%, P < .0001) at 6 months; at 12 months, 61% had ≥ 50% improvement. Change from baseline was statistically significant at 6 months for UUI episodes/day, voids/day (in urinary frequency subjects), and Urgency Perception Score, with improvements in all 3 symptoms maintained through 12 months. Twenty percent of subjects experienced ADEs through 12 months; 1 ADE was serious and was recovered/resolved.
CONCLUSIONS: TITAN 2 met the primary and all secondary objectives by showing a statistically significant improvement of UUI, urinary frequency, and urgency symptoms. Clinical benefits and a favorable safety profile were maintained through 12 months.
MATERIALS AND METHODS: This prospective, multicenter, single-arm investigational device exemption study enrolled eligible overactive bladder subjects with UUI. The primary end point was the percentage of subjects who had ≥ 50% reduction in UUI episodes/day after 6 months. Safety was characterized as the rate of adverse device effects (ADEs). Data are reported as mean ± SD or with 95% CIs.
RESULTS: Of 126 implanted subjects, 95% were female, the mean age was 63 ± 14 years, and BMI was 35 ± 9 kg/m2. The primary objective was met with 59% of subjects achieving ≥ 50% improvement in UUI episodes/day (95% CI: 49%-67%, P < .0001) at 6 months; at 12 months, 61% had ≥ 50% improvement. Change from baseline was statistically significant at 6 months for UUI episodes/day, voids/day (in urinary frequency subjects), and Urgency Perception Score, with improvements in all 3 symptoms maintained through 12 months. Twenty percent of subjects experienced ADEs through 12 months; 1 ADE was serious and was recovered/resolved.
CONCLUSIONS: TITAN 2 met the primary and all secondary objectives by showing a statistically significant improvement of UUI, urinary frequency, and urgency symptoms. Clinical benefits and a favorable safety profile were maintained through 12 months.